Methods for treating, pharmaceutical compositions and uses thereof

Abstract

The present invention relates to methods, pharmaceutical compositions and uses thereof for treating and alleviating Alport syndrome, various aspects and symptoms associated with Alport syndrome in a patient in need thereof comprising administering empagliflozin to the patient.

1 . A method comprising:
 administering empagliflozin to a patient in order to at least one of:   (i) treat Alport syndrome in the patient;   (ii) improve renal function or delay or slow an impairment of the renal function in the patient diagnosed with Alport syndrome;   (iii) delay progression of chronic kidney disease in the patient diagnosed with Alport syndrome;   (iv) treat or alleviate glomerular hypertension in the patient diagnosed with Alport syndrome;   (v) treat, including slowing or reversing the progression of, albuminuria and/or proteinuria in the patient diagnosed with Alport syndrome;   (vi) improve a glomerular filtration rate or delay or slow a decline of the glomerular filtration rate in the patient diagnosed with Alport syndrome.   
     
     
         2 .- 6 . (canceled) 
     
     
         7 . The method according to  claim 1 , wherein the patient has an eGFR equal to or greater than 20 mL/min/1.73m 2 . 
     
     
         8 . The method according to  claim 1 , wherein the adult patient has an eGFR lower than 75 mL/min/1.73 m 2  or lower than 90 mL/min/1.73m 2 . 
     
     
         9 . The method according to  claim 1 , wherein the patient has an elevated protein-to-creatinine ratio (PCR) greater or equal than 300 mg/g creatinine, an elevated level of proteinuria of equal or greater than 200 mg protein per day (24 h urine protein) or an elevated albumin-to-creatinine ratio (ACR) greater or equal than 200 mg/g creatinine or greater or equal than 300 mg/g creatinine. 
     
     
         10 . The method according to  claim 1 , wherein empagliflozin is administered at a dose in a range from 1 mg to 25 mg per day to the patient. 
     
     
         11 . The method according to  claim 10  wherein empagliflozin is administered at a dose of 10 mg per day to the patient. 
     
     
         12 . The method according to  claim 1 , wherein empagliflozin is administered in combination with one or more other therapeutic substances to the patient. 
     
     
         13 . The method according to  claim 12  wherein the one or more other therapeutic substances are selected from the group consisting of angiotensin receptor blockers (ARB), angiotensin-converting enzyme (ACE) inhibitors, beta-blockers, aldosterone antagonists, diuretics, angiotensin receptor-neprilysin inhibitor (ARNi), calcium channel blockers, mineralcorticoid receptor antagonists and ivabradine. 
     
     
         14 . A pharmaceutical composition comprising empagliflozin for use in a method, comprising:
 administering empagliflozin to a patient in order to at least one of:   (i) treat Alport syndrome in the patient;   (ii) improve renal function or delay or slow an impairment of the renal function in the patient diagnosed with Alport syndrome;   (iii) delay progression of chronic kidney disease in the patient diagnosed with Alport syndrome;   (iv) treat or alleviate glomerular hypertension in the patient diagnosed with Alport syndrome;   (v) treat, including slowing or reversing the progression of, albuminuria and/or proteinuria in the patient diagnosed with Alport syndrome;   (vi) improve a glomerular filtration rate or delay or slow a decline of the glomerular filtration rate in the patient diagnosed with Alport syndrome.   
     
     
         15 . The pharmaceutical composition according to  claim 14  comprising empagliflozin in combination with one or more other therapeutic substances selected from the group consisting of angiotensin receptor blockers (ARB), angiotensin-converting enzyme (ACE) inhibitors, beta-blockers, aldosterone antagonists, diuretics, angiotensin receptor-neprilysin inhibitor (ARNi), calcium channel blockers, mineralcorticoid receptor antagonists and ivabradine. 
     
     
         16 . The pharmaceutical composition according to  claim 14 , comprising an amount of 1 to 25 mg of empagliflozin.